The present invention relates generally to portable muscle stimulators for unsupervised personal use. More particularly, the present invention relates to a method of and system for providing a portable muscle stimulator with a mechanism which provides usage monitoring capability.
With the increasing application of high technology to medical applications, there has been a trend in recent years to providing as much care as possible as well as sophisticated medical treatment outside of hospitals. That trend has resulted in an increase in the amount of surgery as well as other types of medical treatment, such as rehabilitation services, being performed outside of hospitals in, for example, ambulatory surgery centers or rehabilitation centers, respectively.
In order to provide an even more cost effective outcome, technology is being applied to obtain the desired medical outcome with medical equipment that can be utilized in the patient's home. In addition to the cost advantages obtained over providing similar treatment in an outpatient setting, the use of such devices by patients in their homes is also more convenient for the patients, since they do not need to travel to an outpatient center for treatment, and they can initiate their own unsupervised treatment at their convenience.
However, several issues which were not concerns when the treatment services were provided to patients in an outpatient or hospital setting, quickly become concerns when patients supervise their own treatment in their own living areas. First, the device which the patients operate to effectuate their prescribed treatment must be easy to use and must be made as safe to use as possible. Second, it would be desirable to be able to monitor and therefore document the use of the device by the patient, in order to assure that the protocol desired for the patient is being utilized. By obtaining such usage data, the physician/health care providers who have developed and/or prescribed the protocol for use by the patient can be satisfied that the patient is indeed performing the desired protocol and the patient's progress can be measured. In addition, the underwriter of the cost of the treatment can be assured that the patient is actually following the protocol. Such monitoring is important in connection with all of the Class II devices, as they are defined in the Food and Drug Administration's Manual, "Classification Names for Medical Devices and In Vitro Diagnostic Products," such as a powered muscle stimulator as defined in 21 C.F.R. 890.5850. Such Class II devices are regulated and require a prescription by a doctor but do not require a high degree of supervision. Thus, such devices are used personally by the patient for whom they are prescribed without any supervision at the time of use.